title: Use of insulin lispro during pregnancy in women with pregestational diabetes mellitus.
abstract: OBJECTIVE
  To assess the safety and efficacy of insulin analogues versus human insulin in pregnant women with pregestational diabetes.
  
  
  METHODS
  We collected data on pregnant women with type 1 or type 2 diabetes who were attended at the Diabetes and Pregnancy Unit between January 1998 and April 2008 (N=351). Two hundred and forty one patients were treated with regular insulin and NPH and 110 were treated with different combinations of insulins including an insulin analogue (most of them with NPH and lispro).
  
  
  RESULTS
  There was no significant difference in terms of congenital malformation rate between groups (3.3% and 3.6%). The group on insulin analogue had slightly higher mean HbA1c during the first trimester than the group on human insulin (6.6 [1.0]% vs 6.9 [1.1]%; P=0,022) and needed smaller insulin doses during whole pregnancy. Severe hypoglycaemia was significantly less frequent among women treated with a rapid insulin analogue (2.3 vs 10.0%; P=0,025). Neonatal hypoglycaemia was significantly more frequent in the group treated with a rapid insulin analogue (34.9 vs 23.6%; P=0.043) due to the concomitant use of an insulin pump. Other obstetric and neonatal variables were not different between the two groups.
  
  
  CONCLUSIONS
  Our study shows that insulin analogues are safe during pregnancy in women with pregestational diabetes mellitus. Overall, glycaemic control, maternal and foetal outcome were similar to those with human insulin. The main advantage with respect to human insulin was to importantly reduce maternal severe hypoglycaemia.
authors.affiliation: Department of Endocrinology, Hospital Universitario La Paz, Madrid, Spain. mgdominguez2002@hotmail.com
authors.forename: María
authors.initials: M
authors.lastname: García-Domínguez
authors.forename: Lucrecia
authors.initials: L
authors.lastname: Herranz
authors.forename: Natalia
authors.initials: N
authors.lastname: Hillman
authors.forename: Pilar
authors.initials: P
authors.lastname: Martín-Vaquero
authors.forename: Mercedes
authors.initials: M
authors.lastname: Jáñez
authors.forename: Elisa
authors.initials: E
authors.lastname: Moya-Chimenti
authors.forename: Luis Felipe
authors.initials: LF
authors.lastname: Pallardo
mesh_terms: D000014:Abnormalities, Drug-Induced; D000328:Adult; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D061268:Insulin Lispro / Q000009:adverse effects / Q000627:therapeutic use*; D007336:Insulin, Isophane / Q000009:adverse effects / Q000627:therapeutic use*; D061386:Insulin, Regular, Human / Q000009:adverse effects / Q000627:therapeutic use*; D016015:Logistic Models; D011247:Pregnancy; D011254:Pregnancy in Diabetics / Q000097:blood / Q000188:drug therapy*; D012189:Retrospective Studies
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061268:Insulin Lispro; D007336:Insulin, Isophane; D061386:Insulin, Regular, Human; C517652:hemoglobin A1c protein, human